FDA Takes Action to Remove Black Box Warnings for Hormone Therapies for Menopause Symptoms

The U.S. Food and Drug Administration (FDA) announced it is beginning to remove “black box” warning labels from hormone replacement therapy (HRT) products used to relieve menopause symptoms, a move Commissioner Dr. Marty Makary said is supported by decades of research on the therapy’s benefits and clinical trials that do not support previous fears linking it to increased breast cancer mortality.

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said at a news conference alongside Makary on Monday that so-called “black box” labels, the strongest warnings for prescription drugs that the agency can require, were designed to “scare women and silence doctors.”

“He warned of diseases and dangers that the data simply did not support. FDA bureaucrats reacted out of fear, not standard science. And instead of correcting the record, the medical establishment doubled down on its groupthink,” Kennedy said. “The consequences have been devastating.”

FDA Commissioner Dr. Marty Makary and HHS Secretary Robert F. Kennedy Jr. announce warning letters to companies selling 7-hydroxymitragynine products during a press conference at HHS headquarters in Washington, DC, on July 29, 2025. (Sauk Loeb/News via Getty Images)

Makary added that a 2002 study known as the Women’s Health Initiative, which fueled concerns about hormone therapy and breast cancer, was “misrepresented and created a fear machine.”

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She wrote in a Monday op-ed in The Wall Street Journal, hours before the official announcement, that HRT, which “consists of estrogen and progesterone (or estrogen alone for women who have had a hysterectomy),” is a “breakthrough for many women.”

“It relieves short-term symptoms of menopause, including hot flashes, night sweats, mood swings, and weight gain, and when started within 10 years of menopause, long-term health benefits that even doctors may not be familiar with have been underestimated.”

Hormone replacement therapy, used to control the symptoms of menopause by supplementing hormones that the body no longer produces in sufficient quantities.

The “black box” warnings, which were first added in 2003, were based on misinterpreted data and deterred millions of women from using HRT, according to the FDA commissioner.

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Makary highlighted a 1991 UC San Diego review that found that HRT can reduce fatal coronary events by about 50% and a 1996 study from the University of Southern California that found that women who used estrogen replacement therapy had a 35% lower risk of Alzheimer’s disease compared to those who did not use it.

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Kelly Casperson, a board-certified urologist, said at the HHS event that the FDA’s move to remove the “black box” warning label would help “correct decades of misleading guidance.”

“The FDA’s decision to remove the boxed warning is not just regulatory,” he said. “It’s revolutionary.”